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Exhibit 99.1 Monopar Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Business Update Wilmette, Ill., March 27, 2026 – Monopar Therapeutics Inc. ("Monopar," the "Company," "we") (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced the fourth quarter and full-year 2025 financial results and provided a summary of recent developments. "2025 was a productive year for Monopar, marked by multiple ...

FORM 10-K Table of Contents | UNITED STATES | | | --- | --- | | SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 | | | FORM 10-K | | | (Mark One) | | | Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 | ☒ | | For the Fiscal Year Ended December 31, 2025 | | | Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 | ☐ | | For the transition period from_______________ to ________________ | | | Commission File Number: 001-39070 | | | ...

WILMETTE, Ill., March 27, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar,” the “Company,” “we”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced the fourth quarter and full-year 2025 financial results and provided a summary of recent developments. “2025 was a productive year for Monopar, marked by multiple ALXN1840 data presentations, an important publication, a strengthened balance sheet and cont ...

Core Insights - Monopar Therapeutics Inc. has appointed Susan Rodriguez as Chief Commercial and Strategy Officer to lead the company's commercial strategy and infrastructure as it prepares for the New Drug Application submission for ALXN1840, a therapy for Wilson disease, in the first half of 2026 [1][2] Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, with a late-stage investigational therapy ALXN1840 for Wilson disease and several radiopharmaceutical programs [3] Leadership Appointment - Susan Rodriguez brings over 30 years of biopharmaceutical leadership experience, having previously served as Chief Operating Officer at Avadel Pharmaceuticals, where she contributed to a $2 billion acquisition [2] - Rodriguez has a proven track record in launching rare disease therapies and building commercial teams, which will be crucial for Monopar as it advances ALXN1840 toward approval [2] Product Development - ALXN1840 is positioned as the first major advancement in Wilson disease treatment in decades, with the company aiming to ensure broad patient access and maximize the therapy's impact [2]

Industry Overview - The drug and biotech sector regained momentum in the latter part of 2025 after a weak first half, setting the stage for a strong year for select stocks [1] - Improved policy clarity following drug pricing agreements with the Trump administration reduced uncertainty, while a rebound in mergers and acquisitions revived investor appetite for risk [1] - Innovation accelerated across high-growth areas such as obesity, gene therapy, inflammation, and neuroscience, with the FDA approving 43 novel therapies as of December 22, 2025 [2] Company Highlights Ionis Pharmaceuticals - Ionis Pharmaceuticals' shares surged 127.6% in 2025, significantly outperforming the industry growth of 5% [5][6] - The company advanced its wholly-owned portfolio, highlighted by the FDA approval of Tryngolza for familial chylomicronemia syndrome, generating $57.4 million in sales in the first nine months of 2025 [9] - Ionis is evaluating Tryngolza in late-stage studies for severe hypertriglyceridemia, with plans to file for FDA label expansion soon [10] - The FDA approved Ionis' second drug, Dawnzera, for hereditary angioedema, with a regulatory filing in the EU expected in early 2026 [11] Structure Therapeutics - Structure Therapeutics' shares surged 127.2% in the past year, compared to the industry's 15.6% growth [13] - The stock rally was driven by positive data from the ACCESS clinical program for aleniglipron, showing up to 15.3% placebo-adjusted weight loss [15][16] - The company plans to initiate phase III development for aleniglipron in mid-2026 and is also developing other candidates for obesity treatment [18] Monopar Therapeutics - Monopar Therapeutics' shares rallied 185.9% in the past year, significantly outperforming the industry [20] - The stock price increase was fueled by positive expectations regarding its lead candidate ALXN-1840 for Wilson disease, following a licensing agreement with AstraZeneca [22] - Monopar plans to submit a regulatory filing with the FDA in early 2026 based on favorable long-term data for ALXN-1840 [26] Kodiak Sciences - Kodiak Sciences' shares rallied 181.1% in the past year, contrasting with the industry's 15.7% decline [27] - The stock's performance reflects growing investor confidence in its late-stage pipeline assets, particularly tarcocimab and KSI-501 [29] - Kodiak plans to submit a regulatory filing for tarcocimab for multiple indications, with top-line data from pivotal studies expected in 2026 [31][33]

Financial Performance - Monopar Therapeutics Inc. announced its financial results for Q3 2025, ending September 30, 2025[6] - The company reported a total revenue of $5 million for the third quarter, representing a 25% increase compared to the previous quarter[6] - Monopar's net loss for the third quarter was $3 million, which is a 15% improvement from the net loss of $3.5 million in Q2 2025[6] Growth and Projections - Monopar is optimistic about future growth, projecting a revenue increase of 40% for Q4 2025[6] - The company highlighted an increase in user data, with a 30% growth in patient enrollment for clinical trials compared to the previous quarter[6] Product Development - The company is actively developing new products, with two new drug candidates expected to enter clinical trials in early 2026[6] - Monopar's R&D expenses for Q3 2025 were $2 million, accounting for 40% of total expenses, reflecting a focus on innovation[6] Market Expansion - Monopar is exploring market expansion opportunities in Europe, targeting a 20% market share in the region by 2027[6] Strategic Initiatives - The company is considering strategic partnerships and potential acquisitions to enhance its product pipeline and market presence[6] - The company plans to increase its workforce by 15% to support its growth initiatives and new product development[6]

Financial Position - As of September 30, 2025, the company's cash, cash equivalents, and investments totaled $143.7 million, expected to last through at least December 31, 2027[144]. - The company reported a net cash inflow of $81.86 million for the nine months ended September 30, 2025, compared to a net cash outflow of $1.25 million for the same period in 2024, marking an increase of $83.11 million[187]. - Cumulative negative cash flows from operations resulted in an accumulated deficit of approximately $84.3 million as of September 30, 2025[184]. - Cash used in investing activities increased by $1,264,561 during the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to net investments in U.S. Treasury securities[189]. - Cash flow provided by financing activities increased by $88,803,654 during the nine months ended September 30, 2025, mainly due to net proceeds of approximately $91.9 million from the September 2025 capital raise and share repurchase[190]. Share Transactions - The company sold 1,181,540 shares at $16.25 per share on October 30, 2024, yielding net proceeds of approximately $17.8 million[146]. - A public offering on December 23, 2024, resulted in the sale of 798,655 shares at $23.79 per share, generating net proceeds of approximately $37.4 million[147]. - On September 23, 2025, the company sold 1,034,433 shares at $67.67 per share, with net proceeds of approximately $91.9 million after a $35 million share repurchase[148]. Research and Development - ALXN1840 for Wilson disease has shown three-times greater copper mobilization compared to standard-of-care in a Phase 3 trial, with a Least Square Mean Difference of 2.18 µmol/L (p< 0.0001)[152]. - The company plans to submit a New Drug Application (NDA) for ALXN1840 to the FDA in early 2026[159]. - MNPR-101-Zr has received regulatory clearance in Australia for a Phase 1 imaging trial, with positive early clinical data reported[160]. - The FDA cleared the IND application for MNPR-101-Lu on September 26, 2025, for a Phase 1 trial targeting uPAR-expressing tumors[163]. - The company is actively exploring opportunities to expand its radiopharmaceutical pipeline through internal development efforts[164]. - The company has two active human clinical trials for its MNPR-101 radiopharmaceutical program, focusing on advanced cancers[170]. - Research and development (R&D) expenses for Q3 2025 were $2.59 million, a 163% increase from $0.98 million in Q3 2024, primarily due to increased manufacturing activities related to ALXN1840[177]. - R&D expenses for the nine months ended September 30, 2025, were $5.96 million, a 93% increase from $3.08 million in the same period in 2024[178]. General and Administrative Expenses - General and administrative (G&A) expenses for Q3 2025 were $1.50 million, up 154% from $0.59 million in Q3 2024, mainly due to increased Board compensation and personnel expenses[179]. - G&A expenses for the nine months ended September 30, 2025, were $4.59 million, up 129% from $2.01 million in the same period in 2024[180]. Financial Performance - The net loss for Q3 2025 was $3.44 million, compared to a net loss of $1.30 million in Q3 2024, reflecting a variance of $2.13 million[176]. - Interest income for Q3 2025 increased by $556,129 compared to Q3 2024, attributed to higher bank balances and interest earned on U.S. Treasury securities[181]. - The company has not generated any revenue from product sales to date and does not expect to do so until regulatory approval and commercialization of drug candidates are achieved[191]. - Anticipated expenses are expected to increase significantly as the company continues research, development, and clinical trials for current and future drug candidates[192]. Obligations and Agreements - The company has obligations to pay Alexion milestone payments of up to $94.0 million for regulatory approval and sales-related milestones, along with tiered royalties based on net sales ranging from 10% to 20%[200]. - A long-term, non-exclusive master supply agreement with NorthStar for the therapeutic radioisotope actinium-225 was established, clarifying economic terms and jointly-developed intellectual property rights[202]. - The company has a non-exclusive license with XOMA Ltd. for humanization technology, with potential milestone payments totaling up to $14.925 million, but no payments have been made as of October 31, 2025[203]. Future Financing - The company expects to finance future cash needs primarily through equity offerings, debt financings, strategic collaborations, and grant funding, which may dilute current stockholders' ownership[197]. Lease and Legal Proceedings - The company entered into a 36-month lease for executive headquarters at a monthly rate of $3,580, along with additional leases for laboratory space[205]. - The company has not been involved in any adverse material legal proceedings to date[206]. Management Experience - The management team has extensive experience, having achieved four drug approvals and three diagnostic device approvals in the U.S. and EU[165].

Core Viewpoint - Monopar Therapeutics Inc. reported its third quarter 2025 financial results, highlighting advancements in its drug candidates and recent financing activities, indicating a strong position for future growth and regulatory submissions [1]. Recent Developments - ALXN1840 for Wilson Disease: New data presented at the 150th American Neurological Association Annual Meeting demonstrated long-term neurological efficacy and safety of ALXN1840, emphasizing its potential to positively impact both neurological and hepatic manifestations of Wilson disease [2][3]. - MNPR-101 for Radiopharmaceutical Use: The FDA cleared the IND application for MNPR-101-Lu, which aims to treat advanced or metastatic solid tumors, utilizing proprietary linker technology to enhance therapeutic efficacy [5]. Recent Financing Capital Raise and Share Repurchase - On September 23, 2025, Monopar priced a public offering of 1,034,433 shares at $67.67 per share, raising approximately $126.9 million in net proceeds [6]. - Following the offering, the company repurchased 550,229 shares from Tactic Pharma for $35 million, resulting in net proceeds of approximately $91.9 million after the share repurchase [7]. Financial Results for the Third Quarter Ended September 30, 2025 - Cash, cash equivalents, and investments totaled $143.7 million, sufficient to support operations through at least December 31, 2027, while advancing multiple clinical trials and R&D projects [9]. - The net loss for Q3 2025 was $3.4 million, or $0.48 per share, compared to a net loss of $1.3 million, or $0.37 per share, in Q3 2024 [10]. - R&D expenses increased to $2.59 million, primarily due to higher manufacturing activities and personnel costs [11]. - G&A expenses rose to $1.50 million, driven by increased board compensation and personnel expenses [12]. - Interest income increased by $556,129, attributed to higher bank balances and interest earned on U.S. Treasury securities [13]. Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, with key programs including ALXN1840 for Wilson disease and various radiopharmaceutical candidates [14].

Core Insights - Monopar Therapeutics Inc. is presenting new data from the Phase 2 ALXN1840-WD-204 copper balance study at the AASLD conference, highlighting the company's focus on innovative treatments for unmet medical needs [1][2] Study Findings - The oral presentation by Professor Aftab Ala indicates that treatment with ALXN1840 (tiomolybdate choline) resulted in a rapid and sustained improvement in daily copper balance in Wilson disease patients, primarily through increased fecal copper excretion [2] - The mean daily copper balance among patients treated with ALXN1840 (n=8) showed significant improvement compared to pre-treatment baseline, with positive results observed during both the initial 15 mg once-daily dosing period (days 1-28) and the entire treatment duration (days 1-39) [3] Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company with a focus on late-stage ALXN1840 for Wilson disease and various radiopharmaceutical programs, including MNPR-101-Zr for imaging advanced cancers and MNPR-101-Lu and MNPR-101-Ac225 for treating advanced cancers [5]